STAT+: FDA launches effort to speed up clinical trials, using AI

STAT PlusBreaking News FDA launches effort to speed up clinical trials, using AI The agency will review trial data in real time from AstraZeneca and Amgen Manage alerts for this article Email this article Share this article By Lizzy LawrenceApril 28, 2026 FDA Reporter Lizzy Lawrence[email protected]Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. WASHINGTON — The Food and Drug Administration on Tuesday announced efforts to make clinical trials more efficient, starting by reviewing data in real time from trials conducted by AstraZeneca and Amgen. The agency also asked the public to weigh in on a potential pilot program to work with companies that use AI to enhance safety monitoring and medication dose selections, identify safety signals, and improve patient recruitment in clinical trials. Advertisement AstraZeneca is conducting a Phase 2 trial of its combination therapy for patients with an aggressive form of lymphoma. The trial will take place at the University of Texas MD Anderson Cancer Center and the University of Pennsylvania. Amgen is conducting a Phase 1b trial of its treatment for small cell lung carcinoma. The trials will rely on a real-time data platform built by Paradigm Health. STAT+ Exclusive Story Already have an account? Log in This article is exclusive to STAT+ subscribers Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts. Already have an account? Log in Monthly $39 Totals $468 per year $39/month Get Started Totals $468 per year Starter $30 for 3 months, then $399/year $30 for 3 months Get Started Then $399/year Annual $399 Save 15% $399/year Get Started Save 15% 11+ Users Custom Savings start at 25%! Request A Quote Request A Quote Savings start at 25%! 2-10 Users $300 Annually per user $300/year Get Started $300 Annually per user View All Plans To read the rest of this story subscribe to STAT+. Subscribe Log In Artificial intelligence, biotechnology, Clinical trials, drug development, FDA, Pharmaceuticals, Policy, STAT+ Submit a correction requestReprints Lizzy Lawrence FDA Reporter Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. Newsletter Your morning rundown of the science, politics, and money driving biotech today Recommended Biotech April 28, 2026 Fauci adviser David Morens indicted on charges of concealing emails, avoiding records requests The Readout April 28, 2026 STAT Plus: Boehringer’s obesity drug shows 16.6% weight loss; more data needed Advertisement Pharma April 28, 2026 STAT Plus: Eli Lilly enlists AI startup for next-generation gene editors Biotech April 27, 2026 STAT Plus: Erasca touts strong, though preliminary, results in trial of pancreatic and lung cancer therapy The Readout April 27, 2026 STAT Plus: Astellas retries XLMTM gene therapy after deaths Subscriber Picks